Bacterial seals

ABSTRACT

Bacterial seals for humans, animals, and the like. An outer sleeve extends through a body opening from the exterior of the body to an interior space therein, this outer sleeve having a tight, intimate engagement with body tissue so that is is securely connected with the tissue. An elongated member is situated within and surrounded by the sleeve and has an extremely close precise fit with the sleeve at the interface between the exterior surface of the elongated member and the interior surface of the sleeve. Through this elongated member it is possible to have any desired type of communication between the exterior of the body and the internal space. A barrier is located at the interface between the elongated member and the sleeve for preventing any bacteriological contamination of the interior body space from the exterior.

Unite States Bucalo 1 June 11, 1974 [5 BACTERIAL SEALS [75] Inventor:Louis Bucalo, l-Iolbrook, NY.

[73] Assignee: Investors In Ventures, Inc, New

York, NY.

[22] Filed: July 10, 1972 [21] Appl. No.: 270,458

[52] U.S. Cl. 128/1 R, 3/1

[51] Int. Cl A611) 19/00 [58] Field of Search 128/1 R, 334 R, 283, 348;'3/1' [56] References Cited UNITED STATES PATENTS 3,216,420 11/1965Smith et a1 .l. 128/283 3,402,710 9/1968 Paleschuck... 128/1 R 3,447,1616/1969 Weikel 128/1 R 3,687,129 8/1972 Nuwayser... 128/1 R 3,704,70412/1972 Gonzales 128/1 R FOREIGN PATENTS OR APPLICATIONS 1,961,5317/1970 Germany 3/1 Primary Examiner-Dalton L. Truluck Attorney, Agent,or FirmSteinberg & Blake [5 7] ABSTRACT exterior surface of theelongated member and the interior surface of the sleeve. Through thiselongated member it is possible to have any desired type ofcommunication between the exterior of the body and the internal space. Abarrier is located at the interface between the elongated member and thesleeve for preventing any bacteriological contamination of the interiorbody space from the exterior.

12 Claims, 7 Drawing Figures 1 BACTERIAL SEALS BACKGROUND OF THEINVENTION The present invention relates to bacterial seals.

Thus, the present invention relates to' structures which will enablemany different types of communication to be achieved between theexterior of a body and an interior space thereof while at the same timepreventing bacterial contamination of the internal body space.

Thus, at the present time there are various types of known devices whichenable desired types of communication between the exterior and interiorof a body such as a human body to be achieved. However, all of theseknown structures are relatively complex. The most serious defectencountered with such structures, however, resides in the fact thatthere is a great likelihood of bacterial contamination of the bodybecause of the possibility of communication between the exterior of thebody and the interior through the structure which is mounted on the bodyto provide a particular type of communication between'the exterior andinterior of the body.

SUMMARY OF THE INVENTION Accordingly it is a primary object of thepresent invention to provide a structure which will give practically anydesired type of communication between the exterior and interior of abody suchas a human body while at the same time reliably preventingbacterial contamination.

Furthermore it is an object of the present invention to provide astructure of this type which is far simpler and far more effective thanknown structures designed for the same purpose.

Yet another object of the present invention is to provide a constructionof this type which is easily mounted in the human body while assuring atight intimate and secure connection between the structure of theinvention and the body of the living being. v

Furthermore, it is an object of the invention to provide a structure ofthis type which enables a bacterial barrier to be'achieved in anexceedingly effective and at the same time simple manner.

According to the invention an outer sleeve means is mounted within anopeningin the body which extends from the exterior'of the body to an.internal space therein, this sleeve means carrying at its exterior ameans for providing a tight secure connection between the sleeve meansand the tissue of the body. An elongated member is situated within andsurrounded by the sleeve means and at the interface between theelongated member and the sleeve means there is an extremely close,precise fit obtained, for example, by initially depositing the sleevemeans directly on the exterior surface of the elongated member. At theinterface between the elongated member and the sleeve means there is abarrier means for preventing bacterial travel between the exterior ofthe body and the interior space thereof so that in this way a reliableprevention of bacterial contamination is achieved. The elongated membermay be used for any number of purposes. For example it may form part ofa valve for achieving incontinence control when the valve is situated inthe male urethra, or it may be used toadjust a device implanted in thebody. It may also be used for providing electrical communication betweenthe exterior and interior of the body, or it may simply have a window toprovide for visual observation of the interior body space.

BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated by way ofexample in the accompanying drawings which form part of this applicationand in which FIG. 1 is a schematic partly sectional elevation of oneembodiment .of the invention;

FIG. 2 is a schematic partly sectional elevation of a second embodimentof the invention;

FIG. 3 is a schematic partly sectional elevation illustrating the mannerin which the invention may be used for incontinence control;

FIG. 4 is a schematic representation of one purpose which may be servedby the structure of the invention;

FIG. 5 is a schematic top plan view of the structure of FIG. 4;

FIG. 6 is a partly sectional elevation of the structure of the inventionillustrating a further manner in which it may be used; and

FIG. 7 is a schematic representation of yet another use to which thestructure of the invention may be put.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to the drawings andto FIG. 1 in particular, there is schematically represented in FIG. 1 awall of tissue 10 forming part of a human body, for example, and havingan exterior surface 12 where the exterior skin of the human being islocated. The opposed surface 14 of the wall 10 forms part of anyinternal space of the human body, or the body of an animal, if desired.Thus, the surface 14 may form part of an elongated body passage throughwhich a fluid flows or it may form part of the interior of an'organ ofthe human body.

The wall M) of the human body is formed with an opening 16 which islined with a sleeve means 18 which carries at its exterior surface ameans 20 for providing a tight, intimate, and secure connection betweenthe wall 10 and the sleeve means 18. The sleeve 18 may be made of amaterial which is compatible with the body, such as gold, and the means20 in the illustrated example takes the form of a fine gold wire whichis wound around and engages the exterior .of the sleeve means 18.Instead of a single strand of wire which is wound several times aroundthe exterior of the sleeve 18 it is possible to use a fine gold wiremesh, for example. In any event, the means 20 provides 'a large numberof interstices into which the tissue 10 grows to provide the tight,intimate and secure connection between the sleeve means 18 and the wall10 in the opening 16 thereof.

An elongated member 22 extends through the sleeve means 18 and isturnable therein. This elongated member 22 has an extremely close,precise fit at the interface 24 between the elongated member 22 and thesleeve means 18. The assembly of the elongated member 22 and the sleevemeans 18 may be carried out in accordance with the teachings of US Pat.No. 3,616,520. Thus, the elongated member 22 is made of a material towhich the sleeve'means 18 will not adhere. The material of the sleevemeans 18 is deposited in' any number of different ways, such aselectrolyti- 3 cally, directly on the exterior surface of the elongatedmember 22, and the deposition is continued until the desired thicknessof the sleeve means 18 is achieved. In this way it is possible toprovide the desired extremely close precise fit between the sleeve means18 and the elongated member 22 while at the same time the latter isturnable within the sleeve means 18 and with respect thereto at theinterface 24.

According to the invention a barrier means 26 is provided to preventbacterial communication between the exterior of the body at the skin 12and the interior space which is defined in part by the inner surface 14of the wall 10. In the example of FIG. 1 the barrier means 26 takes theform of an annular groove 28 formed in the elongated member 22 and aprojection 30 forming part of the sleeve means 18. This projection 30 isformed during deposition of the sleeve means 18 on the member 22 so thata correspondingannular groove 32 forms at the exterior of the sleeve 18which has a uniform thickness due to the deposition of the sleeve means18 on the-member 22. This groove 32 provides further security in theconnection between the sleeve means and the wall because the tissue ofthe latter will grow into the groove 32.

Because of the extremely close and precise fit between the sleeve means18 and the elongated member 22, the projection 30 in the groove 28 willform a barrier through which bacteria cannot travel, so that in this wayabacterial seal is achieved with the structure of FIG. 1.

At its exterior the member 22 may be formed with a non-circular bore 34extending partly into the member 22 along the axis thereof and capableof rcceiving a wrench, such as an-Allen wrench, so that through thisstructure it .is possible to turn the member 22 within the sleeve means18 for any desired purpose.

The embodiment of the invention which is illustrated in FIG. 2 issimilar to that of FIG. 1 except for the structure of the barrier means.Thus it will be seen that FIG. 2 also illustrates the wall 10 having theexterior skin 12 and the interior surface 14 which forms part of aninterior space of the body, and the opening 16 is also lined with asleeve means 18 made of gold and having at its exterior surface a meansin the form of wound gold wire or agold wire mesh to achieve the tight,intimate, secure connection between the sleeve means 18 and the wall 10.In the case of FIG. 2 the sleeve-means does not have an exterior flange,but of course this feature is immaterial. The sleeve means 18 of FIG. 2surrounds and engages with an extremely close precise fit an elongatedmember 40 which is also made, for example, of a material to which thegold will not adhere and on which the gold of the sleeve means 18 isdirectly deposited in a manner described above 'in connection with FIG.1.

In the embodiment of FIG. 2 the elongated member 40 is formed with anannular groove 42 which-is filled with wax, for example, before the goldof the sleeve means 18 is deposited on the elongated member 40. Inaddition the member 40 is formed with a bore 44 which is internallythreaded so that it can be closed by a 010- sure means such as asuitable set screw. The bore 44 in turn communicatesthrough an inclinedbore 46 with the groove 42. At its exterior end the elongated member 40may be formed with notches 48 so that the member 40 can be turned by ascrewdriver, for example, for any desired purpose, as referred to below.

I After the sleeve means 18 has been deposited on the member 40, the waxis removed from the groove 42 by heating the member 40 so that the waxwill melt and will flow out through the bore 46 and the internallythreaded bore 44. Then, after the structure is mounted in the opening 16in the manner shown in FIG. 2, or even before it is mounted therein, asuitable antibiotic material is situated within the annular groove 42 byintroducing this antibiotic through the bore 44 and the inclined bore46. The antibiotic can fill the groove 42 and can extend up the bore 46to the bore 44, and then the latter can be closed with a suitable setscrew.

Thus, the antibiotic in the groove 44 will form a barrier meanspreventing the travel of living bacteria past the groove 42.

With this particular embodiment it is possible from time to time toremove the set screw situated within the internally threaded bore 44 andreplenish the supply of antibiotic by introducing additional antibiotic,if required, through the bore 46.

FIG. 3 illustrates how the invention is used in connection with controlof incontinence. Thus, in this case the outer sleeve means 50 isextended to form a valve housing. The sleeve means 50 is again situatedin an opening 16 in a wall 10 of the human body, this wall 10 in thiscase being part of a penis and being situated at the urethra 52. Thus inthe example of FIG. 3 the inner surface 14 forms part of the urethra.Thesleeve means 50 is again covered at its exterior surface by the means54 in the form of fine gold wire, or a wire mesh, providing the smallinterstices into which the tissue grows so as to provide the securetight connection between the valve housing and the wall 10 as well asthe part of the urethra 52 opposite from the wall 10, as illustrated.The valve housing formed by the sleeve means 50 has an inlet opening 56and an outlet opening 58 in the form of an elongated tube.

The elongated member of this embodiment takes the form of a rotary valvemember 60, and the gold which forms the valve housing is depositeddirectly on the member 60 so as to provide the close precise fitreferred to above. The elongated member 60 in this case terminates atitsinner end in a rotary substantially spherical valve body 62 formedwith the valve opening 64 extending diammetrically therethrough andhaving an axis situated at the elevation of the axis of the tubularoutlet 58. The elongated member or valve member 60 is shown in FIG. 3 inits closed position where the axis of the opening 64 extendsperpendicularly with respect to the axis of the urethra passage 52. Atits outer end the elongated member 60 is formed with a noncircular bore66 capable of receiving a wrench, such-as an Allen wrench, as referredto above, so that it is possible to turn the valve member between theclosed positionshown in FIG. 3 and an open position where the bore 64will assume the dot-dash line position illustrated providing a clearpassage continuously through the urethra. Therefore, in order to controlincontinence it is possible to close the valve so as to prevent urinefrom flowing through the urethra, while at the same time it is possiblewhenever desired to place the valve in its open position permitting freeflow of urine.

In the embodiment of FIG. 3 the elongated member 60 is formed at itsportion which forms the valve stem with an annular groove 68 which isfilled with an antibiotic material '70. The interior portion of thenoncircular bore 66 is circular and internally threaded so as to receivea closure means in the form of a set screw 72. The lower or interior endof the bore 66 communicates through the inclined bores 74 withtheannular groove 68. Thus, by removing the set screw 72 it is possibleat any time to replenish the supply of antibiotic material in theannular groove 70. In this respect the embodiment of FIG. 3 is similarto that of FIG. 2, and of course when the structure of FIG. 3 is formedthe groove 68 is initially filled with wax so that-during dposition ofthe gold which forms the valve housing or sleeve means 50 the groove 68will not become filled with the gold. Thereafter this wax is melted outin the manner referred to above and the antibiotic is supplied with theclosure means 72 reliably retaining the antibiotic-in the groove 68.Thus this embodiment has the bacterial barrier means which preventsbacterial contamination of the interior of the body by travel ofbacteria at the interface between the outer sleeve means 50 and theelongated member 60.

In addition, it is tobe noted that when the valve is in its closedposition shown in FIG. 3, the exterior surface portions of the sphericalvalve body 62 which extend across and close the openings 56 and 58 areexposed to bodily fluids and will receive deposits such as calciumdeposits. Because of the close precise fit, achieving the seal betweenthe sleeve means and elongated member in accordance withthe invention,any turning of the member 60 will result in wiping of the surfacespreviously exposed through the openings 56 and 58 to the interior spaceof the body, so that in this way any deposits such as calcium arereliably cleaned away from the exterior surface of the rotary member,maintaining the latter in a clean condition simply as a result of rotarymovement of the member 60.

The above-described embodiments of the invention, illustrated in FIGS. 1and 2, may be used in a number of different ways. As examples ofpossible uses thereof,

FIGS. 4-7 illustrate some applications. Thus, FIG. 4 illustrates anembodiment similar to that of FIG. 1 where the inner end of member 22 isprovided with an integral extension 80 terminating in a socket wrenchtype of cup 82. The non-circular interior of the wrench or cup 82receives a non-circular rotary adjusting member 84 of an implanteddevice 86 which may, for example, be a pacemaker.

At the exterior of the body, the flange of the sleeve means 18 isextended beyond the outer periphery of the outer flanged end of themember 22. In this way it is possible to provide on the extended flangeof member 18 an index 88, as illustrated in FIG. 5. The outer flange end90 of the member 22 is provided with graduations. Thus, when the wrenchis introduced into the bore 34 in order to make an adjustment, one ofthe graduations can be aligned with the index 88, and in this way it ispossible to know the extent of adjustment of an implanted device such asthe device 86 shown in FIG. 4. Thus, with the particular use of theinvention shown in FIGS. 4 and 5 it is possible while maintaining abacterial seal to provide from the exterior of the body planted deviceand aligned with each other in such a way that turning of the exteriorelement will result in a corresponding turning of the interior element.

FIG. 6 illustrates a rotary member 40 corresponding in all respects tothe member 40 of FIG. 2 and mounted in precisely the same way asdescribed above in connection with FIG. 2 and as shown in FIG. 2. Inthis particular application of theinvention the member 40 is formed withan elongated bore 94 passing therethrough and receiving elongatedelectrical conductors 96. The interior of the bore 94 is sealed with anysuitable sealing material which tightly closes the bore 94 while thesealing material closely surrounds the conductors 96 with the latterbeing embedded in the sealing material in the bore 94 so that there isnot the possibility of bacterial contamination through the bore 94. Withsuch a construction the outer portions of the conductors 96 can beconnected to any suitable electrical device such as a meter, apotentiometer, a battery, etc., and the interior portions of theconductors 96 can be connected to any unit implanted within the body sothatwhile preventing bacterial communication it is possible in this wayto achieve an electrical connection between the interior and exterior ofthe body.

Referring to FIG. 7, the member 98 which is fragmentarily illustratedtherein may take the form either of the member 40 of FIG. 2 or ofthemember 22 of FIG. 1,.with this member being mounted either asillustrated in FIG. 2 or as illustrated in FIG. 1. According to thisembodiment the member 98 is formed with a bore 100 extending completelytherethrough at a location wherethis bore will not interfere with anopening for a wrench, for example, or with an opening such as the recess44 of FIG. 2 through which the supply of antibiotic may be replenished.At its inner end the bore 100 is tightly closed by a transparent plate102 made of a material such as clear glass, a suitable plastic, or thelike, with the outer periphery of the plate 102 being tightly fixedalong its entire periphery to the inner surface of the bore 100 as byusing a suitable glue or the like. Thus, with this embodiment it ispossible to visually observe the interior of the body cavity through thewindow 102.

Thus, FIGS. 4-7, as well as FIG. 3, illustrate some of the possibleapplications of the present invention.

In all of these applications the structure by which the elongated memberis mounted in the opening of the body is exceedingly simple and at thesame time provides a secure tight connection with the body tissue. Anexceedingly great safety with respect to prevention of bacterialcontamination is achieved by way of the very close seal between theinner member and the sleeve means which surrounds the same, this sealbeing achieved by way of the deposited fit according to which the sleevemeans is directly deposited on the elongated member so as to have theclosest possible fit therewith.

As was pointed out above, by choosing for deposition a'material whichwill not adhere to the element on which the material is deposited it ispossible to achieve the close fit of the invention.

However, in addition to the safety achieved with this deposited sealfit, the barrier means of the invention, whether it takes the form ofthe tongue-and-groove type of barrier shown in FIG. 1 or theencapsulated antibiotic as shown in FIG. 2, will provide with the utmostreliability prevention of bacterial contamination.

What is claimed is:

I. For use in the body of a human being, animal, or the like, outersleeve means for lining a body opening extending from the exteriorthereof to an internal body space, said sleeve means having opposed openends respectively adapted to be situated at the exterior of the body andthe internal body space and having an uninterrupted hollow interiorextending between said opposed open ends, and said sleeve means carryingon its exterior surface-a means for providing a tight, sealed engagementbetween tissue of the body and the exterior surface of said sleevemeans, an elongated member situated in and surrounded by said sleevemeans, said elongated member having at an exterior surface thereof aclose, precise fit in said sleeve means at an inner surface of saidsleeve means which definesan interface with said exterior surface ofsaid elongated member, and barrier means situated at said interfacebetween said elongated member and sleeve means for preventingbacteriological communication between the exterior of the body and theinternal space thereof to achieve a bacteriological seal.

2. The combination of claim 1 and wherein one of said surfaces is formedwith a groove and the other of member at said interface.

4. The combination of claim 3 and wherein said groove is formed in saidmember and said projection is formed on said sleeve means.

5. The combination of claim 4 and wherein said sleeve means is in theform of deposited gold.

6. The combination of claim 5 and wherein said means for achieving saidtight engagement between the exterior of said sleeve means and the bodytissue is in the form of fine gold filamentary material surrounding saidsleeve means at its exterior and situated between the latter and thebody tissue for promoting growth of the latter into intimate contactwith the exterior surface of said sleeve means.

7. The combination of claim 1 and wherein said bar.- rier means is inthe form of an annular groove formed at the exterior of said elongatedmember at said interface between the latter and said sleeve means,,andan antibiotic material encapsulated in said groove to prevent travel ofbacteria past said'groove.

8. The combination of claim 7 and wherein said elongated member isformed at an outer end thereof which is accessible at the exterior ofthe body with a recess and with a bore extending from said recess tosaid groove so that the antibiotic material may be replenished throughsaid bore, and closure means situated at said recess for releasablyclosing the latter.

9. The combination of claim 1 and wherein said sleeve means forms avalve housing having openings situated in the body space, and saidelongated member forming part of a valve member rotatable in saidhousing, the close fit between the latter and said valve member beingsufficient to remove during turning of said valve member deposits whichform on the exterior surface of said valve member through said housingopenings.

10. The combination of claim I and wherein said elongated member isadapted to be operatively connected within the body to an instrumentimplanted therein and requiring adjustment from time to time, saidcombination further including scale means situated at said sleeve meansand valve member and visible at the exterior of the body for indicatingthe adjustment.

made by turning said elongated member in said sleeve means.

11. The combination of claim 1 and wherein an elongated electricalconductor means extends through said tion is implanted.

1. For use in the body of a human being, animal, or the like, outersleeve means for lining a body opening extending from the exteriorthereof to an internal body space, said sleeve means having opposed openends respectively adapted to be situated at the exterior of the body andthe internal body space and having an uninterrupted hollow interiorextending between said opposed open ends, and said sleeve means carryingon its exterior surface a means for providing a tight, sealed engagementbetween tissue of the body and the exterior surface of said sleevemeans, an elongated member situated in and surrounded by said sleevemeans, said elongated member having at an exterior surface thereof aclose, precise fit in said sleeve means at an inner surface of saidsleeve means which defines an interface with said exterior surface ofsaid elongated member, and barrier means situated at said interfacebetween said elongated member and sleeve means for preventingbacteriological communication between the exterior of the body and theinternal space thereof to achieve a bacteriological seal.
 2. Thecombination of claim 1 and wherein one of said surfaces is formed with agroove and the other of said surfaces is formed with an annularprojection extending into and filling said groove with a fitsufficiently tight and precise for providing said barrier means whilepermitting said elongated member to turn in said sleeve means.
 3. Thecombination of claim 2 and wherein said sleeve means has a deposited fiton said elongated member at said interface.
 4. The combination of claim3 and wherein said groove is formed in said member and said projectionis formed on said sleeve means.
 5. The combination of claim 4 andwherein said sleeve means is in the form of deposited gold.
 6. Thecombination of claim 5 and wherein said means for achieving said tightengagement between the exterior of said sleeve means and the body tissueis in the form of fine gold filamentary material surrounding said sleevemeans at its exterior and situated between the latter and the bodytissue for promoting growth of the latter into intimate contact with theexterior surface of said sleeve means.
 7. The combination of claim 1 andwherein said barrIer means is in the form of an annular groove formed atthe exterior of said elongated member at said interface between thelatter and said sleeve means, and an antibiotic material encapsulated insaid groove to prevent travel of bacteria past said groove.
 8. Thecombination of claim 7 and wherein said elongated member is formed at anouter end thereof which is accessible at the exterior of the body with arecess and with a bore extending from said recess to said groove so thatthe antibiotic material may be replenished through said bore, andclosure means situated at said recess for releasably closing the latter.9. The combination of claim 1 and wherein said sleeve means forms avalve housing having openings situated in the body space, and saidelongated member forming part of a valve member rotatable in saidhousing, the close fit between the latter and said valve member beingsufficient to remove during turning of said valve member deposits whichform on the exterior surface of said valve member through said housingopenings.
 10. The combination of claim 1 and wherein said elongatedmember is adapted to be operatively connected within the body to aninstrument implanted therein and requiring adjustment from time to time,said combination further including scale means situated at said sleevemeans and valve member and visible at the exterior of the body forindicating the adjustment made by turning said elongated member in saidsleeve means.
 11. The combination of claim 1 and wherein an elongatedelectrical conductor means extends through said elongated member and isfluid-tightly carried thereby for providing an electrical connectionbetween the interior and exterior of the body.
 12. The combination ofclaim 1 and wherein said elongated member is formed with an elongatedbore extending therethrough, and said member carrying at an inner endregion a window through which the inner space of the body would bevisible when said combination is implanted.